Published online Dec 21, 2017. doi: 10.3748/wjg.v23.i47.8395
Peer-review started: July 28, 2017
First decision: August 30, 2017
Revised: September 19, 2017
Accepted: September 26, 2017
Article in press: September 26, 2017
Published online: December 21, 2017
Processing time: 145 Days and 22.7 Hours
To compare the one-week clinical effects of single doses of dexlansoprazole and esomeprazole on grades A and B erosive esophagitis.
We enrolled 175 adult patients with gastroesophageal reflux disease (GERD). The patients were randomized in a 1:1 ratio into two sequence groups to define the order in which they received single doses of dexlansoprazole (n = 88) and esomeprazole (n = 87) for an intention-to-treat analysis. The primary end-points were the complete symptom resolution (CSR) rates at days 1, 3, and 7 after drug administration.
Thirteen patients were lost to follow-up, resulting in 81 patients in each group for the per-protocol analysis. The CSRs for both groups were similar at days 1, 3 and 7. In the subgroup analysis, the female patients achieved higher CSRs in the dexlansoprazole group than in the esomeprazole group at day 3 (38.3% vs 18.4%, P = 0.046). An increasing trend toward a higher CSR was observed in the dexlansoprazole group at day 7 (55.3% vs 36.8%, P = 0.09). In the esomeprazole group, female sex was a negative predictive factor for CSR on post-administration day 1 [OR = -1.249 ± 0.543; 95%CI: 0.287 (0.099-0.832), P = 0.022] and day 3 [OR = -1.254 ± 0.519; 95%CI: 0.285 (0.103-0.789), P = 0.016]. Patients with spicy food eating habits achieved lower CSRs on day 1 [37.3% vs 21.4%, OR = -0.969 ± 0.438; 95%CI: 0.380 (0.161-0.896), P = 0.027].
The overall CSR for GERD patients was similar at days 1-7 for both the dexlansoprazole and esomeprazole groups, although a higher incidence of CSR was observed on day 3 in female patients who received a single dose of dexlansoprazole.
Core tip: No existing report has investigated the short-term clinical effects of dexlansoprazole 60 mg vs esomeprazole 40 mg. This study compared the one-week clinical effects of a single dose of the two drugs for grades A and B erosive esophagitis. We enrolled 175 adult patients with gastroesophageal reflux disease (GERD) and randomized them in a 1:1 ratio into a dexlansoprazole (n = 88) or esomeprazole group (n = 87) for an intention-to-treat analysis (ITT). The primary end-points were the complete symptom resolution (CSR) rates at days 1, 3, and 7. The CSRs for both groups were similar at days 1, 3 and 7. In the subgroup analysis, female patients achieved higher CSRs in the dexlansoprazole group than in the esomeprazole group at day 3 (38.3% vs 18.4%, P = 0.046). In the esomeprazole group, female sex was a negative predictive factor for CSR at post-dose day 1 [OR = -1.249 ± 0.543; 95%CI: 0.287 (0.099-0.832), P = 0.022] and day 3 [OR = -1.254 ± 0.519; 95%CI: 0.285 (0.103-0.789), P = 0.016]. This pilot study suggested that the overall CSR rates for GERD patients were similar at days 1 through 7 for both the dexlansoprazole and esomeprazole groups, although a higher CSR was observed at day 3 in female patients who received a single dose of dexlansoprazole.